Routine Post-Operative Supplemental Nutrition
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Esophageal Cancer, Esophagectomy
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Tube Feeding
Type: Dietary Supplement
Overall Status
Recruiting
Summary
Patients undergoing an esophagectomy will be randomized to receive either (1) routine post-operative tube feeding for 1 month post-operative or (2) usual practice, which is tube feeding to continue in the hospital until the patient is taking adequate nutrition by mouth at POD#8, or upon discharge.

Specific Aim 1 is to determine the occurrence of common complications and readmissions post-operatively between the two patient groups. The investigators hypothesize that routine use of tube feeding may reduce the occurrence of post-operative complications.

Specific Aim 2 is to determine if routine dietary supplementation with enteral tube affects recovery and QOL after esophagectomy. The investigators hypothesize that routine post-operative supplementation will enhance patients recovery and QOL.

For esophagectomy specifically, there is very limited literature evaluating the complication rate and QOL associated with the length of post-operative tube feeding and adequate nutritional requirements. Small randomized studies have not shown a benefit to routine tube feeding, although the numbers were very small, ranging from 12-70 per group. The investigators will randomize 200 patients for the purpose of this study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients undergoing an elective esophagectomy

- Jejunal feeding tube placed at the time of surgery

Exclusion Criteria:

- Emergent esophagectomy procedure

- Less than 18-years of age

- Inability to provide informed consent or to complete testing or data collection

- Unwillingness to be randomized

- Tube feeding dependent on discharge
Location
University of Michigan Health System
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Shari Barnett, BS - 734-936-4561 - shbailey@umich.edu
Start Date
November 2014
Completion Date
April 2020
Sponsors
University of Michigan
Source
University of Michigan
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page